Recruiting

Observational Study

Sponsor:

Case Western Reserve University

Code:

NCT06093906

Conditions

Posttraumatic Stress Disorder

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Positive Processes and Transition to Health

Progressive Muscle Relaxation

Study Details

Brief summary:

The R33 will be a randomized controlled trial to replicate changes in the targets (unproductive processing, avoidance, reward deficits) from the R61 phase in a larger sample of 135 participants who have experienced a destabilizing life event involving profound loss or threat, report persistent stressor-related symptoms of PTSD and/or depression, and are elevated on symptoms related to 2 of the 3 therapeutic targets. Additionally, this study will examine Positive Processes and Transition to Health (PATH)'s impact on stressor-related psychopathology in comparison to Progressive Muscle Relaxation (PMR). In the R33 phase, the investigators will examine changes in target mechanisms predicting improvements in PTSD and depressive symptoms, as well as feasibility and acceptability. Patients will receive 6 sessions of PATH or PMR (with 2 boosters, if partial responders). Primary targets will be assessed at pre-treatment, week 3, post-treatment, and at 1- and 3-month follow-up; secondary targets at pre-treatment, weekly during treatment, post-treatment, and at 1- and 3-month follow-ups.

Conditions

Posttraumatic Stress Disorder

Major Depressive Disorder

Study ID

NCT06093906

Start date

Sep 12, 2023

Status verified date

Aug, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Destabilizing life event involving profound loss or threat, with a minimum duration of 12 weeks since the event, but occurred within the last 5 years.
  • Between the ages of 18 and 65.
  • Elevated target: Scores of at least moderate (1 or higher) on at least 2 of the 3 target mechanisms: re- experiencing or ruminative processing of the destabilizing event (PSS-I items: 1, 2, 3, 4 or QIDS-C item 11), avoidance (PSS-I items 6, 7, 8), or reward deficits (PSS-I items 12, 13, or QIDS-C item 13).

Exclusion Criteria:

  • Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by DSM-5.
  • Current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan).
  • Severe self-injurious behavior or suicide attempt within the previous three months.
  • Unwilling or unable to discontinue current cognitive behavioral psychotherapy.
  • No clear memory of the destabilizing event or event occurred before age 3.
  • Unstable dose of psychotropic medications in prior 3 months.
  • Ongoing intimate relationship with the perpetrator (in assault related event).
  • Current diagnosis of a substance use disorder (DSM-5).

Study Design

Enrollment

135 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Positive Processes and Transition to Health (PATH)

PATH includes six 60-90 min, weekly sessions, with two booster sessions for partial responders. Session 1 provides the PATH rationale and a review of life events (PATH of life: negative and positive). A rationale for an explicit focus on positive events/emotions will be provided. Sessions 2-4 focus on a verbal narrative of the destabilizing life event, reminiscence and processing of a major positive life event, and real-life practice to enact what was taught. Sessions 5 focuses on constructive processing and provides opportunity for integration and consolidation of learning. Session 6 focuses on future negative and positive events to promote application of new learning and resilience. Booster sessions focus on positive and negative life events since the last session and adaptive processes (constructive processing, approach, and reward). All sessions will include cultivation and elaboration of positive emotions to promote engagement and to build on the benefits of positive emotions.

active comparator: Progressive Muscle Relaxation (PMR)

PMR will be adapted from Berstein, Borkoveck, and Hazlett- Stevens (2000). PMR will be conducted in six, 60-90 min individual weekly sessions with a study therapist. Muscle groups are tightened and then relaxed with the attention of the patient focused on the contrast between tension and relaxation. Through regular practice, the person becomes more aware of tension in the body and can induce relaxation as needed (Field, 2009). During the six sessions of training, patients will be encouraged to practice PMR and learn how to deliberately induce physical relaxation to reduce stress and mental tension. Sessions will move from relaxation of 16-muscle groups to 7 muscle groups, 4 muscle groups, and finally to relaxation by recall. Patients will be instructed to practice daily, if possible, but at least two or three times a week, and to integrate the practice into their daily life. They will be provided with audio recordings and homework reporting forms to assist their home PMR exercises.

Interventions

Positive Processes and Transition to Health

See arm/group description for details regarding this intervention

Progressive Muscle Relaxation

See arm/group description for details regarding this intervention

Primary outcome measure

  • Affective Updating Task [ Time Frame: Change from baseline score at 6 weeks (immediately post treatment) ]
  • Idiographic Behavioral Approach Task [ Time Frame: Change from baseline score at 6 weeks (immediately post treatment) ]
  • Probabilistic Reward Task [ Time Frame: Change from baseline score at 6 weeks (immediately post treatment) ]

Central Contacts and Locations

Central contacts

Noni Shemenski, BA

216-368-0338ptsdlab@case.edu

Locations

University of Delaware

Recruiting

Newark, Delaware, United States, 19716

Contacts

Matt Paszkiewicz, BA

3028312215mattpasz@udel.edu

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Noni Shemenski, BA

2163680338noni.shemenski@case.edu

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Sarah Cornell-Maier, BA

2066853617cornelsm@uw.edu

More Information

Sponsor

Case Western Reserve University

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Case Western Reserve University on 2026-08-19.